Lead R&D technologist then Bioprocess Lab head.Our team is in charge of the development of an R&D and pilot manufacturing site dedicated to therapeutic mAbs. This includes cell line, upstream & downstream technology design, scaling up and transfer. While the site is yet to be launched, my role involves:- collaborating with CDMO subcontractors to design and execute experiments based on DoE and QbD principles;- researching, designing and evaluating materials, assemblies, processes, and equipment for our lab and pilot pipeline, such as culture mediums, resins, disposables, bioreactors, chromatographs, filtration systems, etc.;- developing URSs, SOPs, protocols, reports, etc. to ensure smooth operations and record-keeping of all project phases;- implementing and upholding GLP and GMP practices, drafting LIMS structure of the department;- contributing to the site layout and personnel allocation for the upcoming launch, suggesting training tools and employee skill grades;- collaborating with the engineering, analytical and QA/QC teams on product feasibility, quality, GMP batch management, and automatization;- staying updated on the latest scientific literature and industry trends, and attending industry conferences;- troubleshooting and resolving any technical issues related to experiments, processes, or equipment.

Leveraged my background in scaling-up, technology transfer, and GMP documentation to specialize in ensuring seamless transitions from laboratory to manufacturing, while optimizing processes and adhering to quality standards. Employed a bottleneck approach and statistics to evaluate and mitigate technology risks, collaborated closely with R&D and QA/QC to ensure alignment, and rigorously worked on reducing labor costs and human factor in transfer.

My roles at Biocad varied greatly as I took up projects at various stages of the product design cycle both as researcher and supervisor. These included: Biosimilar and original therapeutic mAbs, Lentiviral vectors for CAR-T therapy, Adenoviral vectors for gene therapy, and Adenoviral and AAV vaccines. I also explored experimental approaches for peptide synthesis as an alternative to microbial cultivation.My technical expertise spans both downstream and upstream processes. I am proficient in cell line screening for mammalian (CHO, HEK293) and bacterial cells with farther cultivation fed-batch or perfusion technology. Additionally, I practiced RP-HPLC, AC, IEC, MMC chromatography, depth filtration, and TFF (ultra & diafiltration). My expertise in chemical synthesis for peptides (HE-SPPS) and oligonucleotides, includes solid-phase (CPG) synthesis.Throughout my journey, I've actively contributed to core product development stages, spanning: feasibility tests & proof of concept for certain tools or approaches, cell line & technology design or optimization, scaling up, and pilot unit. This required maintaining seamless collaboration and steady communication between R&D teams, service and SCADA engineers, manufacturing sites, QA/QC or GMP regulations specialists.